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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/24/2009
 
Trade Name:  Famvir
 
Generic or Proper Name (*):  famciclovir
 
Indications Studied:  Treatment of children 1 month  12 years of age w/ herpes simplex (HSV) & 1  12 years w/ varicella zoster (VSV)
 
Therapeutic Category:  Antiviral
 
Ages Studied:  1 month - <1 year
 
Study #:  3
 
Study Type:  Safety/Pharmacokinetic
 
Study Design:  Open label/Population Pharmacokinetic
 
No Patients:  18
 
No Centers:  10
 
No Countries:  3
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  5
 
Other:  5
 
White:  8
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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